Magnesium Sulfate as an Adjuvant to Propofol During Consious Sedation in Colonoscopy

Magnesium Clinical Trial

Official title:

Magnesium Sulfate as an Adjuvant to Propofol During Consious Sedation in Adult Patients Undergoing Colonoscopy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06131905
• Other study ID #: Magnesium in colonoscopy
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: January 1, 2024
• Est. completion date: December 1, 2025

Study information

• Verified date: December 2023
• Source: Assiut University
• Contact: Mohamed Sayed Mahmoud Sayed, Master
• Phone: 01091383026
• Email: ms0109138[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Colonoscopy is one of the most commonly performed outpatient procedures throughout the world as a screening, diagnostic, and therapeutic tool to evaluate the large intestine from the distal rectum to the cecum.Propofol is the most commonly used hypnotic agent in sedation during endoscopic procedures for its advantages of fast onset and quick recovery. However, propofol may cause respiratory depression and cardiovascular events, which are easier to appear in cases of old age and high speed administration of propofol.Magnesium is a non-specific calcium channel inhibitor and a non-competitive N-methyl-D-aspartate(NMDA)receptor antagonist, which has analgesic and mild sedative properties .

Description:

Colonoscopy is one of the most commonly performed outpatient procedures throughout the world as a screening, diagnostic, and therapeutic tool to evaluate the large intestine from the distal rectum to the cecum . Colonoscopy is currently an important examination method for colorectal diseases. It can provide clear images of lesions and provide biopsy for biopsy. It can improve the accuracy and sensitivity of colorectal cancer diagnosis .The most common complications in gastrointestinal endoscopy are not related to the procedure, but they are related to sedation; they include cardio- respiratory adverse events such as hypoxemia, hypoventilation, apnea, dysrhythmias, hypotension and vasovagal episodes .Propofol is the most commonly used hypnotic agent in sedation during endoscopic procedures for its advantages of fast onset and quick recovery. However, propofol may cause respiratory depression and cardiovascular events, which are easier to appear in cases of old age and high speed administration of propofol . Moreover, high doses of propofol may cause dose-dependent hemodynamic instability in older or feeble patients. Therefore, it is essential to minimize the dosage of propofol to prevent cardiopulmonary complications associated with sedation, especially in the elderly, by combining with an adjuvant medication. Although benzodiazepines or opioids combined with propofol can reduce the consumption of propofol, elderly patients usually feature a higher overall body fat content than younger patients which may delay the metabolism of lipid-soluble propofol, opioid, and benzodiazepines . Magnesium is the fourth most plentiful cation in the body and the second most plentiful intracellular cation after potassium. Approximately one half of total body magnesium is present in bone and 20% in skeletal muscle. Magnesium is necessary for the presynaptic release of acetylcholine from nerve endings and may produce effects similar to calcium-entry-blocking drugs . Magnesium is a non-specific calcium channel inhibitor and a non-competitive N-methyl-D-aspartate(NMDA)receptor antagonist, which has analgesic and mild sedative properties . It has been demonstrated that intravenous administration of magnesium sulfate can reduce the overall use of intraoperative propofol and the postoperative analgesia requirement effectively in various types of surgery .These findings implied that magnesium sulfate may be used as a promising adjuvant drug for colonoscopy sedation due to its analgesic and sedative properties .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• 1. The subject is scheduled for elective colonoscopy. 2. The subject is = 40 years and = 70 years. 3. Both sexes. 4.No obvious abnormalities in preoperative ECG, blood routine, electrolytes, and other tests. 5. ASA class 1-3.

Exclusion Criteria:

• 1.Subject is known or believed to be pregnant or lactating women. 2. Patients are known hypersensitivity to any of the drugs that would be used in the study. 3. Severe cardiac, renal, lung, or liver diseases. 4. Hypotension (systolic blood pressure< 90 mm Hg), uncontrolled hypertension (systolic blood pressure> 170 mmHg, diastolic blood pressure> 100mmHg). 5. Chronic Opioid Use (daily or almost daily use of opioids for> 3 months). 6. Patients that are immunologically compromised. 7. Sleep apnea syndrome or difficult airway. 8. preexisting hypoxemia (Spo2< 90 %). 9. History of adverse events with prior sedation. Additionally, patients who had taken any sedative drugs within the previous 24h

Related Conditions & MeSH terms

• Intraoperative Analgesia
• Magnesium

Intervention

Drug:
• Magnesium Sulfate
40 mg/kg magnesium sulfate diluted with normal saline to a total volume of 100 ml was administered for 15 min.plus ,An initial bolus dose of 1 mg/kg propofol was administered over 30 is followed by a continuous intravenous infusion of propofol at a maintenance dose of 2 mg/kg/h
• Propofol
An initial bolus dose of 1 mg/kg propofol was administered over 30 is followed by a continuous intravenous infusion of propofol at a maintenance dose of 2 mg/kg/h

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (8)

Cote GA, Hovis RM, Ansstas MA, Waldbaum L, Azar RR, Early DS, Edmundowicz SA, Mullady DK, Jonnalagadda SS. Incidence of sedation-related complications with propofol use during advanced endoscopic procedures. Clin Gastroenterol Hepatol. 2010 Feb;8(2):137-4 — View Citation

De Oliveira GS, Bialek J, Fitzgerald P, Kim JY, McCarthy RJ. Systemic magnesium to improve quality of post-surgical recovery in outpatient segmental mastectomy: a randomized, double-blind, placebo-controlled trial. Magnes Res. 2013 Oct-Dec;26(4):156-64. doi: 10.1684/mrh.2014.0349. — View Citation

Herroeder S, Schonherr ME, De Hert SG, Hollmann MW. Magnesium--essentials for anesthesiologists. Anesthesiology. 2011 Apr;114(4):971-93. doi: 10.1097/ALN.0b013e318210483d. — View Citation

Liu J, Liu X, Peng LP, Ji R, Liu C, Li YQ. Efficacy and safety of intravenous lidocaine in propofol-based sedation for ERCP procedures: a prospective, randomized, double-blinded, controlled trial. Gastrointest Endosc. 2020 Aug;92(2):293-300. doi: 10.1016/j.gie.2020.02.050. Epub 2020 Mar 7. — View Citation

Lu Z, Li W, Chen H, Qian Y. Efficacy of a Dexmedetomidine-Remifentanil Combination Compared with a Midazolam-Remifentanil Combination for Conscious Sedation During Therapeutic Endoscopic Retrograde Cholangio-Pancreatography: A Prospective, Randomized, Single-Blinded Preliminary Trial. Dig Dis Sci. 2018 Jun;63(6):1633-1640. doi: 10.1007/s10620-018-5034-3. Epub 2018 Mar 29. — View Citation

Olgun B, Oguz G, Kaya M, Savli S, Eskicirak HE, Guney I, Kadiogullari N. The effects of magnesium sulphate on desflurane requirement, early recovery and postoperative analgesia in laparascopic cholecystectomy. Magnes Res. 2012 Jul;25(2):72-8. doi: 10.1684/mrh.2012.0315. — View Citation

Rex DK, Khalfan HK. Sedation and the technical performance of colonoscopy. Gastrointest Endosc Clin N Am. 2005 Oct;15(4):661-72. doi: 10.1016/j.giec.2005.08.003. — View Citation

Wernli KJ, Brenner AT, Rutter CM, Inadomi JM. Risks Associated With Anesthesia Services During Colonoscopy. Gastroenterology. 2016 Apr;150(4):888-94; quiz e18. doi: 10.1053/j.gastro.2015.12.018. Epub 2015 Dec 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total consumption of propfol	Calculate the total dose of propofol used for each case	During procedure
Secondary	sedation time	Measure sedation time during and after procedure	During procedure and One hour after procedure